OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE

OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE is an FDA 510(k)-cleared medical device (K973793) manufactured by Olicon Imaging Systems, Inc.. This device is classified under the Radiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 16, 1997. Regulation: 8.